– From Regulator’s Perspective

December 12 – 13, 2019

Hyderabad, TS, India

This new and important two-day workshop on Aseptic Processing, Validation and Challenges – From Regulator’s Perspective is extremely useful for people who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot or commercial setting. This aseptic training course is ideally suited to management teams, industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries.

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety. This course will also review the guidance provided in USP <1116> to ensure compliance with regulatory expectations are met.



The manufacture of aseptically produced sterile products represents the greatest level of risk to the public and as a result there are numerous requirements that companies must abide by for compliance. This training will cover not only the current regulations as set by the FDA but also those required by the European Union (EU) GMPs. This will include the main areas of focus by regulatory auditors, expectations for the qualification of equipment and utilities, along with environmental monitoring, media fills and personnel qualification to name a few.

As expected, training of both personnel and management is an increasing area of concern and this seminar will review some proposed reasons for operator error that regulators review to help determine other quality systems that may be impacted depending on the category to which operator error is associated with. Actual cases will be highlighted for some of the reasons listed.

This workshop will help you to develop practical cost effective quality management systems through this training course for pharmaceutical industries to implement effective QMS. We know how important it is to integrate regulatory, market and customer requirements for your complete product range into a streamlined Quality Management System (QMS). Our aim is to help you protect patient health and protect your business from regulatory and commercial risk by Practical Training of quality management systems.

This workshop will discuss the importance of establishing metrics, as well as, how to utilize those metrics to drive Quality Culture. This course will also discuss the latest draft guidance from the USFDA Office of Manufacturing and Product Quality (OMPQ), EU-Eudralex GMP, PIC(s) GMP and WHO-PQP.


  • Explain the difference between Aseptic and Bulk processing
  • Understand facility and personnel requirements necessary to maintain microbial control
  • Explain basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product
  • Understand the gowning requirements associated with different cleanroom classifications
  • Explain basic principles of aseptic processing, including:
    • Cleanliness classifications
    • Process differences between aseptically produced and terminally sterilized product
  • Relation of manufacturing and handling procedures to sources of product contamination
  • The differences between cleaning, disinfection and sanitization
  • Proper cleaning / disinfectant technique
  • Elements of a robust environmental program and why EM is important
  • The role of isolator technology
  • The purpose of media fills, and elements critical to their success
  • Identify behaviors that are or are not appropriate when working in controlled areas, and why
  • Identify ways that they can impact/improve site-specific EM and aseptic behavior issues


  • Quality Assurance Management and Staff
  • Quality Control Management and Staff
  • Research and Development Management and Staff
  • Regulatory Affairs Management and Staff
  • Manufacturing Management and Staff
  • Engineering Management and Staff
  • Operations Management and Staff
  • Production Management and Staff
  • Validation Management and Staff
  • Process Owners
  • Documentation Management and Staff
  • Quality Auditors

DAY 1 : (8:30 AM – 5 PM)

Registration: 8.30 AM – 9 AM

1. What Regulatory is demanding today:

  • Latest regulatory requirement of FDA and EU (European Union) guidelines for manufacturing of aseptic process
  • What regulator see on site during regulatory inspections and most common cited drug GMP deficiencies
  • Review in detail the qualification activities expected of facilities, equipment, utilities and personnel and data integrity (ALCOA+)

2. Microbiology – Main strength:

  • The role of environmental monitoring
  • Types & sources of microorganisms
  • The impact of microorganisms on product and patient health and
  • Methods used for environmental monitoring programs

3. Aseptic Process – Important traits:

  • Cleanliness and disinfection
  • Terminal sterilization vs. Aseptic Processing
  • Relation of manufacturing and handling procedures to sources of
    product contamination
  • The differences between and the purposes of cleaning, disinfection
    and sanitization
  • Proper cleaning tools and techniques
  • The role of isolator technology

DAY 2 : (9 AM – 5 PM)


1. Clean Area Behavior – Training and monitoring:

  • How to gown properly
  • Personnel behavior in a cleanroom – Human as a source of
    contamination and errors
  • Practices – Do and Don’t
  • How to review -EM/aseptic behavior observations/risks/OOS/OOT
  • Importance of personnel training and control of microbiological contamination

Discussion: Ways to change/improve/eliminate these behaviors & risks

2. Aseptic Validation – Media Fill and importance:

  • The purpose of media fills, and elements critical to their success
  • How to Perform a Successful Media Fill
  • Sterile Filtration Validation Requirements

3. Handling Deviations & OOS/OOT – Proper investigations:

  • Issue of deviations and out of specification results (OOS)
  • Expectations for the investigation of these issues
  • Categories being discussed to classify the reasons for operator


  • Discuss the importance and expectations for a change control program as a method of assuring a state of control
  • Review example of a change control SOP and the form used for their documentation, evaluation and approval.


Mercure Hyderabad KCP, Banjara Hills

Hyderabad, TS, India

December 12 – 13, 2019

Water Systems



Kalpesh Kumar Vaghela

Validation Expert

Kalpesh Kumar Vaghela, is the CEO of Infra Control Systems. He has 30 years experience as Software Validation Specialist, Expert Trainer CSV, cGMP, Data Integrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9, Risk Assessment. He has also worked in Elecronics and Instrumentation Engineering fields. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve Compliance by training and motivating professionals for Right First Time Approach. He has supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits, as a consultant.

Over 10 year of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela an expert in special Data integrity Audit for Pharma Industry. He has worked with and trained professionals in numerous major Indian companies. He has close to a decade of international experience of working with companies located in USA, Canada, South America, Norway, Africa, Middle East, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.

Mr. Vaghela has joined hands with Compliance Trainings as an Expert Trainer and Consultant with a common mission to share knowledge and empower the Indian Life Sciences Industry.

G. Sundar

PharmQA Consultant

Mr. Sundar Ganesan is a quality practitioner with 24 + years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA and Japan guidelines. He assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems so that the company can succeed. Mr. Ganesan currently working as Director-Consultant at PharmQA Compliance services an independent consultant firm partners with US and Europe.

Brian G. Nadel

ex-FDA Official

Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.

Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for a large pharmaceutical manufacturer. Previously, he was Senior Manager in another large US pharmaceutical manufacturer where he held the position of Pre-Approval Inspection Manager in the R & D Quality Assurance Department. He started his career as an Investigator for the US FDA as Drug Specialist in the New York City area. He was then promoted to the FDA’s Centre for Drug Evaluation and Research (CDER) in Rockville, MD, where he served as a Compliance Officer in the Office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District offices for regulatory actions such as Warning Letters, Seizures, Consent Decrees, and Injunctions.

Mr. Nadel holds a Bachelors degree in Biology and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at several industry forums.

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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at info@compliancetrainings.in

Payment Policy:

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Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

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Written cancellations through email (from the person who has registered for this conference) received at least 12 business days prior to the start date of the event will receive a refund – minus a Rs. 3000 administration fee. No cancellations will be accepted – nor refunds issued – within 12 business days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees (Rs. 3000) could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

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